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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. DYNASTY® PC SHELL 48MM GROUP B HIP COMPONENT

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MICROPORT ORTHOPEDICS INC. DYNASTY® PC SHELL 48MM GROUP B HIP COMPONENT Back to Search Results
Model Number DSPCGB48
Device Problem Loss of Osseointegration
Event Type  Injury  
Manufacturer Narrative

This event will be updated once the investigation is complete. Trends will be evaluated.

 
Event Description

Allegedly, patient underwent thr. X rays showed loose and dislodged cup. Underwent the revision surgery on (b)(6) 2020 where the mpo 28 mm femoral head was up-sized to a 36mm. Mpo bone screws were changed from 1. 5 cm and 2. 5 cm to a 2 cm screw. The mpo cup and liner were replaced with another manufacturer implant. (b)(4).

 
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Brand NameDYNASTY® PC SHELL 48MM GROUP B
Type of DeviceHIP COMPONENT
Manufacturer (Section D)
MICROPORT ORTHOPEDICS INC.
5677 airline rd.
arlington TN 38002
Manufacturer (Section G)
MICROPORT ORTHOPEDICS INC.
5677 airline rd.
arlington TN 38002
Manufacturer Contact
5677 airline road
arlington , TN 38002
9018674771
MDR Report Key9821750
Report Number3010536692-2020-00227
Device Sequence Number1
Product CodeLZO
Report Source Manufacturer
Source Type DISTRIBUTOR
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 03/11/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/11/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberDSPCGB48
Device Catalogue NumberDSPCGB48
Device LOT Number1687372
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date02/19/2020
Event Location No Information
Date Manufacturer Received02/19/2020
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient TREATMENT DATA
Date Received: 03/11/2020 Patient Sequence Number: 1
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